A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC

This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.

Trial Details

NCT ID
NCT06306456
Phase
PHASE1 / PHASE2
Sponsor
Suzhou Genhouse Bio Co., Ltd.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • GH21
  • Tagrisso
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Changsha, Hunan, China|28.19874,112.97087
  • Nanjing, Jiangsu, China|32.06167,118.77778
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);
  • Male or female subjects aged ≥18 years;
  • Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement:
  • Phase Ib： patients with disease progression previously at least treated with third-generation EGFR-TKIs and platinum-containing chemotherapy;

For full eligibility, visit ClinicalTrials.gov.

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